Specialist I, LIMS Administrator

Location
Baltimore (Camden), MD, US
Posted
Apr 23, 2021
Ref
726224900
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I. JOB SUMMARY
The LIMS Administrator provides support for all administrative functions involving the global Laboratory Information Management System (LIMS) including system configuration, troubleshooting issues, user access, reporting, authoring SOP's, and ensuring cGMP compliance in the LIMS business processes. The LIMS Administrator must understand database structure, auditing functions, report query configuration, as well as facilitate and support improvements to the business processes through the use of electronic systems.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Lead/Project Manager for the LIMs project and implementation at the Emergent Camden site (this includes raw materials, in process and final product testing and stability).
• Individual must possess project management skills so that they can work with the employees at Camden while meeting schedules and . Schedule/timeline management is required.
• Must report out to QA management routine status and system updates.
• Serve as a technical expert to assist and provide support to end users for LIMS application Camden facility.
• Provide support and maintenance, program modifications, performance tuning, problem solving, gathering and writing technical specifications.
• Participate in team projects (local and global).
• Gather and analyze user requirements, development, testing and implementing applications, training users as well as documenting the implementation process.
• Diagnose system problems and develop/coordinate resolutions.
• Work closely with other functional departments and users to generate user requirements and understand system functionality and use, as well as assist in implementation of new functionality.
• Design of new functionality and overall system improvements.
• Primary responsibility is to perform administrative activities for the LIMS software including (but not limited to):
o User account administration
o System configuration
o Change Request administration
o Report generation
o Data export
o Database management / validation
o System troubleshooting
• Assist with the validation of system improvements (drafting user requirements, PQ protocols, and execution of protocols).
• Author and collaborate on SOPs, Deviations, CAPA's and Change Controls as necessary.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education:
• Bachelor's degree preferred or appropriate level of relevant work experience demonstrated. Chemistry degree a plus.

Experience:
• 5-8 years' experience within a cGMP / FDA / Biotechnological / Pharmaceutical environment.
• Previous experience performing LIMS administration related activities.
• 21 CFR Part 11 compliance in a GMP/GLP regulated industry.

Skills:
- Strong written and oral communications skills
- High level of motivation and independence
- Basic skills and fluency in LIMS, Adobe, Microsoft Word, Outlook and Excel
- Strong analytical, troubleshooting, and problem-solving abilities
- Ability to work independently and in teams
• Knowledge of LabVantage software is a plus
• Must have prior experience with managing a LIMS regarding writing code and troubleshooting in the system.
• Must have experience with laboratory testing methods, equipment.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

.buttontextd24067979861e38d a{ border: 1px solid transparent; } .buttontextd24067979861e38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }